1. Good Clinical Practice
Presented by:-
Mr. Swapnil L. 1

2. Good Clinical Practices
Presented by:-
Mr. Swapnil L. Patil
M.Pharm
Department of Pharmaceutics
Pad. Dr. D. Y. Patil College of Pharmacy,
Akurdi, Pune, Maharashtra, India, 411018 .
Mob.09730306520
2

3. Contents
 Glossary
 Principles of GCP
 IEC/IRB Responsibilities
 Investigator Responsibilities
 Sponsor Responsibilities
 Protocols and Amendments
 Investigator’s Brochure
 Essential Documents 3

4. Glossary
Adverse drug reaction (ADR)
Serious Adverse Event (SAE)
Audit
Blinding/masking
Investigator
Protocol
Sponsor
4

5. History of Good Clinical Practice
 Prior to an actual set of guidelines to follow for good clinical
practice, clinical studies were dangerous and could result in
serous disease, or possibly death.
 The Nuremburg Code of 1947
 Experiments performed in Germany during WWII opened the eyes of
the world for guidance for clinical testing on humans.
 The code did set ethical guidelines, but it lacked legislation to back it
up.
 Declaration of Helsinki
▪ In 1964, the World Medical Association established
recommendations guiding medical doctors in biomedical research
involving human subjects. These guidelines influenced national
legislation, but there was no set standard between nations. 5

6. GOOD CLINICAL
PRACTICE
FDA ICH
21 CFR International
• Electronic Docs. • glossary
• Inf. Consent • principles
• Financial Disclosure • IRBs
• IRBs • Investigator
• IND regs. • Sponsor
• Essential Docs
35

7. ICH Guidelines
 ICH Guidelines are divided into 4 main topics:
 Quality Topics – relate to chemical and pharmaceutical quality
assurance
e.g. Q1 Stability Testing
 Safety Topics – relate to preclinical studies
e.g. S1 Carcinogenicity Testing
 Multidisciplinary Topics – cross-cutting topics
which don’t fit into one of the other categories
e.g. M1 Medical Terminology
 Efficacy Topics – relate to clinical studies in human subjects
 e.g. E6 Good Clinical Practice;
 e.g. E2A Clinical Safety Data Management: 7
 e.g. E9 Statistical Principles for Clinical Trials

8. FDA Regulations
21 C.F.R. Part 312, Subpart D (Duties of
Sponsors, Investigators)
– 21 C.F.R. Part 50 (Informed Consent)
– 21 C.F.R. Part 56 (Institutional Review
Boards)
– 21 C.F.R. Part 54 (Investigator Financial
Disclosure)
8

9. Good Clinical Practice (GCP) is defined as a
‘standard for the design, conduct,
performance, monitoring, auditing,
recording, analyses and reporting of clinical
trials that provides assurance that the data
and reported results are credible and
accurate, and that the rights, integrity and
confidentiality of trial subjects are
protected’
9

10. Good Clinical Practice (GCP) is an
international ethical and scientific quality
standard for designing, conducting,
recording, and reporting trials that involve
the participation of human patients.
Compliance with this standard provides
public assurance that the rights, safety and
well-being of trial patients are protected and
clinical trial data are credible. 10

11.  Are mainly focused on the protection of human rights
in clinical trial.
 Provide assurance of the safety of the newly
developed compounds.
 Provide standards on how clinical trials should be
conducted.
 Define the roles and responsibilities of -
 Clinical Sponsors,
 Clinical Research Investigators,
 Clinical Research Associates, And
 Monitors.
11

12. Principles of ICH GCP
1. Clinical trials should be conducted in accordance with the ethical
principles that have their origin in the Declaration of Helsinki, and
that are consistent with GCP and the applicable regulatory
requirements.
2. Before a trial is initiated, foreseeable
risks and inconveniences should be Benefits RISK
S
weighed against the anticipated benefit
for the individual trial subject & society.
A trial should be initiated and continued only if the anticipated
12
benefits justify the risks.

13. Principles of ICH GCP Continued
3. The rights, safety, and well-being of the trial subjects are
the most important considerations and should prevail
over interests of science & society.
4. The available non-clinical & clinical information on an
investigational product should be adequate to support the
proposed clinical trial.
5. Clinical trials should be scientifically sound, and
describe in a clear, detailed protocol.
6. A trial should be conducted in compliance with the 13
protocol that has received prior IRB (or IEC) approval.

14. Principles of ICH GCP Continued
7. The medical care given to, and medical decisions made
on behalf of, subjects should always be the
responsibility of a qualified physician or, when
appropriate, of a qualified dentist.
8. Each individual involved in conducting a trial should be
qualified by education, training and experience to
perform his or her respective tasks.
9. Freely given informed consent should be obtained from
every subject prior to clinical trial participation.
14

15. Principles of ICH GCP Continued
10. All clinical trial information should be recorded, handled,
and stored in a way that allows its accurate reporting,
interpretation, and verification.
11. The confidentiality of records that
could identify subjects should be
protected, respecting the privacy
and confidentiality rules in accordance
with the applicable regulatory
compliance.
15

16. Principles of ICH GCP Continued
12. Investigational products should be manufactured,
handled, and stored in accordance with applicable good
manufacturing practice (GMP). They should be used in
accordance with the approved protocol
13.Systems with procedures that assure the quality of every
aspects of the trial should be implemented.
16

17. Institutional Review Board (IRB),
Independent Ethics Committee (IEC)
 A formally designated group that oversees research
involving human subjects.
 Approves and disapproves human subject research.
 According to the standards of the community or the
institution, the IRB/IEC may require modifications to a
protocol to ensure patient safety.
17

18. IRB Function
•The primary function of an IRB/IEC is to safe guard the
rights ,safety ,and well being of all trial subjects. This is
accomplished by initial, continuing and annual review.
•An IRB should consist of members who collectively have
the qualifications and experience to review and evaluate
the science , medical aspects, and ethics of the proposed
trial.
18

19. IRB Members
1.A minimum of five (5) members.
2.One member whose concern is not scientific.
3.One member who has no personal or familial
relationship to the institution or trial site.
4.Any member with a conflict of interest may not
participate in any part of the review or vote (except to
provide requested information).
5.Individuals with special expertise may be invited to assist
with areas of unique or complex nature. These will not be
voting members.
6.A list of IRB/IEC members and their qualifications 19
should be maintained.

20. IRB/Ethics Committee
All studies must be approved prior to recruiting
participants
IRB must review all documents given to participants
Reporting AEs and Deviations from protocol to the IRB
Maintenance of Records
20

21. Investigator Responsibilities
Adequate Resources
Recruitment
Time
Qualified Staff
Facilities
Training
21

22. Investigator Responsibilities
Medical Care
A qualified MD (or dentist) responsible for
trial-related medical decisions
Provide adequate medical care for AEs or other
significant medical condition
Inform PCP about participation in trial
Make a reasonable effort to ascertain why
participant withdrawals from study
22

23. Investigator Responsibilities
Compliance with Protocol
Investigator should sign off on protocol
Investigator should not implement deviations
from protocol
If deviations occur, they should be documented
and reported at once to the sponsor, the IRB
and other regulatory authorities
23

24. Investigator Responsibilities
Progress Reports Safety Monitoring
Written summary of trial SAEs should be reported
status to the IRB immediately
Written reports to the AEs should be reported
sponsor or regulatory according to sponsor
authority of any changes guidelines
affecting the trial Supply sponsor & IRB
with requested materials
on participant deaths
24

25. Investigator Responsibilities
Premature Termination Final Reporting
or Suspension Inform IRB of study
Promptly inform trial completion & a summary
subjects of the trial’s outcome
Assure appropriate Provide sponsor &
therapy & follow-up regulatory authorities
Inform sponsor, with all required reports
regulatory authorities &
IRB
25

26. Investigator’s Brochure
Defined as a compilation of the
clinical and nonclinical data on
the investigational product(s)
that are relevant to the study of
the product(s) in human
subjects.
26

27. Clinical Trial Protocol
General Information
Background Information
Trial Objectives & Purpose
Trial Design
Selection & Withdrawal of Participants
Treatment of Subjects
Assessment of Efficacy
Assessment of Safety
27

28. Sponsor Responsibilities
Quality Assurance & Quality Control
Provide written SOPs
Secures agreement between all parties
Data handling
Contract Research Organization (CRO)
Hired by the sponsor to implement trial-related duties
Medical Expertise
Designated medical personnel to advise on trial-related
medical questions and problems
28

29. Sponsor Responsibilities
Trial Design
Designs CRFs
Planning analyses
Trial Management, Data Handling,
Recordkeeping, & Independent Data Monitoring
Committee (DMC)
Qualified personnel to supervise overall conduct of the
study
DMC assesses the progress of the clinical trial
Maintain SOPs for electronic data processing
Inform Investigator of guidelines for record retention 29

30. Essential Documents for the Conduct of a
Clinical Trial
Preclinical trial
commencement
During clinical conduct
of trial
After completion or
termination of trial
30

31. Storage of Essential Documents
Sponsor Rule: refer to study
protocol
FDA Rule: 2 options
2 years following marketing of
the drug or,
2 years after IND application
is withdrawn if drug was not
marketed
31

32. References
32

33. References
http://www.fda.gov/oc/gcp/guidance.htm
http://www.clinicaltrials.gov/
http://www.fda.gov/oc/ohrt/irbs/websites.html
http://ohrp.osophs.dhhs.gov/
http://privacyruleandresearch.nih.gov/
http://en.wikipedia.org/wiki/ICH-GCP
Handbook: good laboratory practice (GLP): quality
practices for regulated non-clinical research and
development -2nd ed., WHO Library Cataloguing-in- 33
Publication Data, 2nd ed., 7,15-20.

34. References
OECD Principles of Good Laboratory Practice (as
revised in 1997)". OECD Environmental Health
and Safety Publications (OECD) 1. 1998.
http://www.oecd.org/document/63/0,2340,en_264
9_34381_2346175_1_1_1_37465,00.html.
Schneider, K (1983(Spring)). "Faking it: The case
against Industrial Bio-Test Laboratories". Amicus
Journal (Natural Resources Defence Council): 14-
26.
http://planetwaves.net/contents/faking_it.html. 34

35. References
Tweedale, AC (2011). "Uses of ‘Good Laboratory
Practices’ by regulated industry and agencies, and
the safety of bisphenol A". J Epidemiol
Community Health (BMJ Group) Online First: 15
February 2011. doi:10.1136/jech.2010.127761.
Webster, Gregory K. et al. (2005). "JALA
Tutorial: Considerations When Implementing
Automated Methods into GcP". Journal of the
Association for Laboratory Automation (Elsevier)
10 (3): 182–191. doi:10.1016/j.jala.2005.03.003 35

36. Thank you……….
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